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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

The purpose of this submission is to expand the Dentium Prosthetics to include the Scan Abutments and Comfort Caps.

Scan Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final abutment.

Comfort Caps are used provisionally as an accessory to protect the dental abutment before final prosthesis.

They have the design feature that enable to transmit position and angulation data of implant when taking a digital impression using an intra-oral scanner.

The Scan Abutments and Comfort Caps are prefabricated and made of Ti-6AI-4V ELI (ASTM F136) or PEEK(ASTM F2026). Scan Abutments are compatible with Dentium Implant(K041368 Implantium and K160965 SuperLine or K153268 NR Line) and Comfort Caps are compatible with Dentium Prosthetics(K052957 Implantium and K172640 SuperLine or K153268 NR Line)

This document is a 510(k) Pre-Market Notification from the FDA regarding dental devices (Scan Abutments and Comfort Caps). It focuses on demonstrating substantial equivalence to previously cleared devices, rather than establishing performance against specific acceptance criteria for a novel AI/ML device.

Therefore, many of the requested details about acceptance criteria and study design (especially those related to AI/ML performance, ground truth, human readers, and training/test set specifics) are not applicable to this type of regulatory submission.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The primary "acceptance criterion" for a 510(k) is the demonstration of substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use as a predicate and the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness and are as safe and effective as the predicate.
• Reported Device Performance (as demonstrated for Substantial Equivalence):
  • Indications for Use: The subject device has the same indication for use as the primary predicates: "Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation."
  • Technological Characteristics Comparison (Tables provided in Section 7): The document provides detailed comparison tables for Scan Abutments (vs. K172640, K153268, K173374, K172160) and Comfort Caps (vs. K171142, K172160). These tables demonstrate similarities in:
    • Device name, Manufacturer, 510(k) Number (where applicable)
    • Indication for use
    • Materials (Ti-6Al-4V ELI, PEEK – demonstrated to be identical to or commonly used in predicates)
    • Form (Preformed)
    • Sterilization (Non-sterile, similar to primary predicates; note on sterile reference predicates)
    • Use (Prescription)
    • Single Use Only (Yes)
    • Design characteristics: Diameter, Length, Connection type, Scanning feature (for Scan Abutments), Surface treatment.
  • Performance Data (Non-clinical):
    • Steam sterilization validation (ISO 17665-1 and ISO 17665-2), demonstrating a sterility assurance level (SAL) of 10-6. (This is a specific performance metric).
    • Biocompatibility of Ti-6Al-4V ELI (ASTM F136) was demonstrated by referencing a previous submission (K172640) using the same materials and manufacturing processes.
    • Cytotoxicity testing of PEEK (ASTM F2026) was performed according to ISO 10993-5.

N/A (Not Applicable) for this type of submission:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific "test set" in the context of an AI/ML model for performance evaluation is described. The performance data relates to material properties and sterilization, not diagnostic/AI performance on a dataset.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not a concept for these mechanical/material devices.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is compliance with material standards, sterilization standards, and functional equivalence to predicates.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this FDA document is for a medical device (dental abutments and caps) seeking 510(k) clearance based on substantial equivalence. It does not involve AI/ML components or comparative effectiveness studies of human readers, thus many of the questions are not relevant.

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